In 2005, the FDA approved the initial application of our core technology, marketed as Coaptite® injectable implant as a bulking agent to treat women who have stress urinary incontinence due to poorly functioning urethral sphincter muscles. The device consists of CaHA particles 75 to 125 microns in diameter suspended in a gel carrier similar to that used in Radiesse® dermal filler. COAPTITE implant is injected into the space around the urethra near the bladder. After injection, COAPTITE implant bulks the tissue near the urethral sphincter, enabling the sphincter to function more effectively. The PMA approval was based on a clinical study that demonstrated statistical equivalence in the first 12 months to the Contigen Collagen Implant, a leading bulking agent for stress urinary incontinence marketed by C.R. Bard. In this study, the COAPTITE implant-treated group demonstrated continued improvement at 24 months. COAPTITE injectable implant is the first and only urology bulking agent with clinically proven two-year effectiveness.
In 2006, BioForm entered into an exclusive distribution agreement with Boston Scientific to sell COAPTITE implant in the United States for female stress urinary incontinence.
Coaptite Injectable Implant is approved for soft tissue augmentation in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult females.
For more information on Coaptite Injectable Implant, please go to the Coaptite injectable implant (This link will take you to the Boston Scientific website)
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